NCT03202277

Brief Summary

Type 2 diabetes (T2D) is a national epidemic and current lifestyle programs and medications are not effectively managing the crisis. This project aims to test a novel smartphone-delivered intervention that simultaneously targets multiple health behaviors (i.e., sleep, sedentary behavior, physical activity,dietary intake) within clinical settings at a large Veteran Health Administration regional hospital. If effective, this project has potential for large-scale implementation nationwide through the VA healthcare system and broad applicability for other populations at T2D risk as well as other disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 17, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2019

Completed
Last Updated

May 11, 2020

Status Verified

May 1, 2020

Enrollment Period

2.2 years

First QC Date

June 23, 2017

Last Update Submit

May 8, 2020

Conditions

Diabetes Mellitus, Type 2

Keywords

physical activity, sleep, sedentary behavior, dietary intake, smartphone

Outcome Measures

Primary Outcomes (2)

  • HbA1c

    Circulating levels of Hemoglobin A1c

    9 months

  • Fasting glucose

    Fasting levels of glucose

    9 months

Secondary Outcomes (4)

  • Sleep duration (minutes/night) measured by wrist actigraphy

    9 months

  • Sedentary behavior (minutes/day) measured by wrist actigraphy

    9 months

  • Moderate-vigorous physical activity (minutes/day) measured by wrist actigraphy

    9 months

  • Dietary quality measured by the NCI dietary factor screener

    9 months

Study Arms (2)

BeWell24 smartphone app

EXPERIMENTAL

Smartphone app, linked with commercial activity monitor, to support lifestyle changes in physical activity, sleep, sedentary behavior, and dietary intake.

Behavioral: BeWell24 smartphone app

Health education smartphone app

ACTIVE COMPARATOR

Smartphone app with basic health education content, designed to control for non-specific treatment effects and match for smartphone app novelty.

Behavioral: Health education app

Interventions

BeWell24 smartphone appBEHAVIORAL

This app delivers an evidence-based suite of lifestyle interventions targeting behavior change in sleep, sedentary behavior, physical activity, and dietary intake. The app connects with a commercially available activity monitor to provide real-time feedback on behaviors over time.

BeWell24 smartphone app
Health education appBEHAVIORAL

This app delivers basic health education and hygiene content related to sleep, sedentary behavior, physical activity, and dietary intake.

Health education smartphone app

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans ages 18 and older
  • Regularly use an appropriate Apple (iOS6 or higher) or Android (2.3 or higher) smartphone or tablet device
  • Risk for "prediabetes" based upon clinician judgment - clinicians may rely on laboratory data review in the prior 12 months including: (a) HbA1c 5.7-6.4%; and (b) glucose, HDL-cholesterol, triglycerides, and weight

You may not qualify if:

  • long distance or insufficient transportation to the Veterans hospital to make participation in quarterly visits difficult;
  • severe personal, health, cognitive or psychological conditions that prevent participation or severely limit lifestyle changes
  • limited physical mobility, untreated sleep disorder, or other underlying disorder that requires treatment or would make lifestyle change contraindicated
  • current participation in other diet, weight loss, or lifestyle programs
  • recent or imminent changes in medications that would substantially alter glucose metabolism (e.g., steroids, anti-depressive medications associated with weight gain)
  • recent weight gain or loss of more than 10 kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Phoenix VA Healthcare System

Phoenix, Arizona, 85012, United States

Location

Arizona State University

Tempe, Arizona, 85281, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2017

First Posted

June 28, 2017

Study Start

September 17, 2017

Primary Completion

December 14, 2019

Study Completion

December 14, 2019

Last Updated

May 11, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)